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The latest Biotech News and Views |
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| Good morning! The Novo Nordisk Foundation wants to prevent the next pandemic. The Danish foundation has pledged up to DKK 200M ($31M) to create the Global Pathogen Analysis Platform, a new AI-powered system designed to detect and track infectious diseases worldwide. Developed in collaboration with DTU, the University of Copenhagen, Statens Serum Institut, and Imperial College London, the platform will integrate genomic data from viruses, bacteria, and parasites with environmental and mobility data to identify emerging threats early and will be freely accessible to scientists and health authorities globally, with special support for low- and middle-income countries. Let's just hope the AI actually learns to detect pathogens — not to design them. |
| Enjoy today's read! |
| - Joachim E. |
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| SNAPSHOT |
| Regeneron's gene therapy restores hearing in children with genetic deafness |
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| Regeneron's experimental gene therapy, DB-OTO, significantly improved hearing in children with a rare genetic form of deafness, with most regaining moderate to normal hearing. |
| Why it matters: If approved, DB-OTO could become the first gene therapy for congenital deafness, potentially replacing lifelong reliance on cochlear implants for thousands of children worldwide. |
| Backstory: Some babies are born profoundly deaf due to mutations in a gene crucial for hearing. Regeneron's therapy delivers functional copies of that gene directly into the inner ear via the same procedure used for surgical implants. |
| Big picture: The success of DB-OTO signals a major leap in gene therapy, particularly for neurological and sensory disorders. It also reflects Regeneron's growing push into genetic medicine, amid a competitive but cooling biotech market. |
| The trial in detail: In a study of 12 children, 9 reached moderate to normal hearing levels within 6 months. One toddler progressed to normal hearing, identifying spoken words without visual cues. The therapy proved effective across different ages, not just in very young children, as previously thought. Despite the drug's efficacy, minor side effects were typical of ear surgeries; two serious events resolved without lasting issues. |
| What's next: Regeneron plans to file for FDA approval by year-end, facing competition from companies like Eli Lilly's Akouos. A possible obstacle could be the still unknown long-term durability that insurers are concerned about, given the expected high price tag. |
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| PRESENTED BY AXOL BIOSCIENCE |
| Why are drug developers turning to iPSCs? |
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Late-stage drug failures are costly and all too common. The solution? Human iPSC models.
They offer better human relevance than traditional models, scale from individual patients to large populations, and reflect real demographic diversity. This makes them powerful tools for patient stratification, trial design, and de-risking drug development.
Want to explore how iPSCs are transforming research and drug discovery? |
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| SNIPPETS |
| What's happening in biotech today? |
| Backward data: Tvardi Therapeutics' STAT3 inhibitor TTI-101 failed to demonstrate meaningful efficacy in a phase 2 trial for idiopathic pulmonary fibrosis (IPF), with results showing no significant improvement over placebo and alarmingly high discontinuation rates due to gastrointestinal side effects (56.7% and 62.1% for low and high doses, compared to 10.3% in the placebo group). The trial included 88 patients, many also taking Boehringer Ingelheim's approved IPF drug Ofev, which was associated with even higher adverse event rates. Lung function declined more in the TTI-101 groups than in the placebo group. Tvardi is now analyzing the data further while shifting focus to its cancer candidate TTI-109. |
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| PIPE dream: ADC Therapeutics has announced a $60 million private placement (PIPE) financing, led by TCGX, with participation from Redmile Group and others. The proceeds will support the commercial expansion of its CD19-directed antibody-drug conjugate ZYNLONTA, strengthen its balance sheet, and fund general operations. The company expects to close the financing by October 27, 2025, and estimates Q3 2025 net product revenue of $15.8 million and cash holdings rising to $292.3 million post-PIPE. |
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| SNAP AGAIN |
| Excellergy raises $70M to reinvent allergy treatment with multi-action drug |
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| Biotech startup Excellergy secured $70 million to advance a new class of allergy drugs that act on the immune system in three distinct ways for faster, more comprehensive relief. This amount came from investors that include Red Tree, Samsara BioCapital, and Decheng Capital. |
| Why it matters: Current treatments for IgE-mediated allergies, like Xolair, are limited and slow-acting. Excellergy's trifunctional approach could offer a breakthrough for millions with food allergies, chronic hives, and other allergic conditions. |
| Backstory: Founded in 2021 with backing from Red Tree Venture Capital, Excellergy is building on research from Stanford and the University of Bern. Its drug targets IgE, the antibody responsible for allergic reactions, by both removing it and suppressing the immune cell receptor it binds to. |
| Big picture: With over $1 billion invested in immunology startups this year, Excellergy joins a crowded but fast-growing field, competing with major players like Regeneron and Novartis. The company believes many patients are still under- or untreated, leaving a large untapped market. |
| The trial in detail: The drug class is called effector cell response inhibitors (ECRIs). Early clinical trials will begin in 2026, with food allergies and urticarias as likely lead indications. Unlike Xolair, ECRIs also remove IgE already bound to receptors, without triggering immune overreaction. |
| What's next: Early clinical trials will begin in 2026, with food allergies and urticarias as likely lead indications. |
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| Upcoming events |
| Frankfurt, 28-30 October 2025 – CPHI |
| Vienna, 3-5 November 2025 – BIO-Europe 2025 |
| Boston, 13-14 November, 2025 – Pharma Partnering Summit |
| Dubai, 17-18 November, 2025 – World Biotechnology and Bioengineering Congress |
| Paris, 24-25 November, 2025 – 2nd International Congress on Virology, Emerging Diseases and Vaccines |
| Brussels, 4-5 December, 2025 – BIOVERSE Europe 2025 |
| London, 9-10 December, 2025 – SynbiTECH |
| San Diego, 14-17 December, 2025 – Antibody Engineering & Therapeutics |
| San Francisco, 10 January – Sachs Annual Oncology Innovation Forum |
| London, 19 January – Bioseed |
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| Disclaimer: The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical or AZoNetwork. |
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